NCT02204345

A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology

Open Label Phase Ib/II, Multicenter Study of the Combination of RO5479599 With Carboplatin and Paclitaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) of Squamous Histology Who Have Not Received Prior Chemotherapy or Targeted Therapy for NSCLC

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.

Conditions

• Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.
DRUG	Paclitaxel	Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.
DRUG	RO5479599	RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-07-30
• Last updated: 2017-01-25

Locations

6 sites across 3 countries: Canada, Denmark, Spain